CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
BTX-A +1 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05822323
NCT05822323N/ACompleted

Retrospective Evaluation Of The Effect Of Botulinum Toxin-A Injection Applied To The Mental Muscle On Free Gingival Graft Operation: A Randomized Controlled Clinical Study

Kevser Sokmen·interventional·Posted Apr 20, 2023·Updated Apr 20, 2023

In Brief

A clinical study evaluating BTX-A and free gingival graft for Gingival Recession, Localized. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The aim of this study was to examine the effects of Botulinum Toxin-A (BTX-A) injection to the mental muscle on the free gingival graft (FGG) operation. Forty patients with Miller class III gingival recession and keratinized gingival insufficiency in their lower 1st incisors were divided into 2 groups as FGG operation (n=20) and 5 unit (U) BTX-A injection into the mental muscle immediately after FGG operation (n=20). Periodontal parameters (plaque index (PI), gingival index (GI), probing pocket depth (PPD), keratinized gingival amount (KGA), attached gingival amount (AGA)) were measured from the lower 1st incisors at the beginning and at the 1st, 3rd and 6th months after the operation, clinical attachment level (CAL), gingival thickness (GT), gingival recession amount (GRA), gingival recession width (GRW) and root closure percentage (RCP (%)) were evaluated. There was no statistically significant difference in terms of PI and GI levels (p\>0.05). The PPD levels of the study group at the postoperative 3rd month was found to be statistically significantly lower than the control group (p\<0.05). While the change in GT and RCP (%) levels were found to be statistically significantly higher than the control group, the change in GRW and CAL levels were statistically significantly lower (p\<0.05). According to the results of this study, it can be stated that BTX-A injection applied to the mental muscle after FGG operation may have positive effects in terms of KGA, AGA, GT, RCP (%), GRW and CAL parameters.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedApr 20, 2023
Enrollment StartOct 1, 2019
Primary CompletionOct 1, 2020
Study CompletionOct 1, 2021
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 3.2 years ago

Interventions

BTX-Aother

Vials of 100 U Allergan Botox® (Allergan, Inc., Irvine, California) were diluted with 2 ml of physiological saline and made ready for use. The midline was determined at the mentum region. 5 U of BTX-A was injected into the mental muscle approximately 1 cm away from the chin tip and the midline

free gingival graftprocedure

The mandibular first incisor was treated with FGG operation due to Miller class III gingival recession and insufficient amount of keratinized gingiva.